FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1080189
·
Received July 22, 2008
Report
- Report Number
- 2182207-2008-04216
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 23, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. CATHETER.
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL FELT THE CATHETER HAD A POTENTIAL OCCLUSION. NO PATIENT SYMPTOMS WERE REPORTED. IT WAS UNKNOWN IF A CATHETER DYE STUDY HAD BEEN DONE; A ROTOR STUDY WAS NOT PERFORMED. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT INJURY. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | EXPLANTED:| IMPLANTED:| PROGRAMMER MDOEL 8840 LOT# UNKNOWN| CATHETER MODEL 8709 LOT# N067726030 |